1. Purpose
Manage the standard solution and test solution well to ensure the normal operation of the assay.
2. Scope of application
It is suitable for the preparation of standard solutions, calibration and preparation of test solutions.
3. Responsibility
Laboratory technicians should strictly follow the operating procedures, and the QC supervisor is responsible for supervising the implementation of the procedures.
4. Definition
USPUnited States Pharmacopoeia
CPChinese Pharmacopoeia
vs.standard solution
5. Safety Precautions
none
6. Procedures
6.1. The preparation and calibration of the standard solution should be strictly in accordance with the methods specified in USP25 or CP2000 unless otherwise specified.
6.2. Each batch of standard solution should have a clear batch number, and its batch number establishment rule is VSxxxx (year) xx (month) xx (serial number). Example: the first batch of standard solution calibrated in May 2000, its batch number is VS20000501.
6.3. Use a special standard solution for preparation and standardization records (see Appendix 1). The records should be neat, complete, accurate and timely.
6.4. The two-person recheck system is implemented for the calibration solution. After the first calibrater calibrates, another person independently operates the recheck calibration. If there is no special regulation, the relative standard deviation of a single person should be within 0.1%, and the relative standard deviation of two people should be within 0.2%. , otherwise it should be re-calibrated.
6.5. The calibration person is responsible for the calibration results, and the approver is responsible for reviewing the calculation results and approving the use of standard solutions.
6.6. Unless otherwise specified, the standard solution is generally valid for 3 months, and the appearance should be checked before each use, and rechecked and calibrated if necessary. For commonly used standard solutions, new solutions should be prepared and calibrated before the validity period. For infrequently used and unstable The standard solution can be prepared or calibrated at any time.
6.7. The standard solution label (see Appendix 2) should be clearly marked with items such as name, molar concentration, calibration temperature, calibration date and expiration date.
6.8. If there is no special regulation on the preparation method of the test solution, the USP25 method is generally used. If the method of the Chinese Pharmacopoeia 2000 is used for the test, the solution should be prepared by the method of the Chinese Pharmacopoeia.
6.9. Unless otherwise specified, the validity period of the test solution is generally half a year, and should be checked frequently. If the appearance changes, stop using it and prepare the test solution again.
6.10. For test solutions that use volatile organic compounds as solvents, use suitable ground-mouth stoppers or rubber stoppers to prevent solvent volatilization: for those with bad smell, seal the stoppers and store them in a fume hood.
6.11. The test solution label (see Appendix 3) should clearly indicate the name, preparation method (USP or CP), preparation date, preparation person, and if necessary, indicate the solvent used. Each bottle of solution should have a clear solution number, and its number establishment rule is xx (year) xx (month) xx (day) xx (serial number) Example: the first solution prepared on February 3, 2001, its solution number for 01020301.
7. Reference
"CHINA Standard Operating Procedures for Drug Inspection"
USP25
CP2000
8. Distribution department
Quality Management Department
9. Revision history:
none
